Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT04548973
This study proposed applying intravenous Esketamine to cesarean section in parturient, detecting the plasma concentration of Esketamine in maternal blood, neonatal umbilical venous blood and umbilical arterial blood when the baby is delivered ketamine blood drug concentration, observing vital signs, adverse visual analog pain score (VAS), and sedation score (Ramsay) in parturient, neonatal Apgar score 1, 5 to 10 minutes after birth, the umbilical arterial blood gas and neurobehavioral scores (NBNA) 2, 24 hours after the birth. This study aims to address placental transfer, metabolism and analgesic and sedative effects in neonates and parturients of Esketamine so as to explore the feasibility, efficacy and safety of Esketamine as adjuvant medication for cesarean section.
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Notify Me20 year–40 year
Female
Interventional
Phase 4
Hangzhou, Zhejiang, 310000, China
4.2 maternal hemodynamic indexes such as heart rate (HR), mean arterial pressure (MAP) and respiratory mechanics indexes such as pulse oxygen saturation (SpO2) and shout at the end of the co2 partial pressure (PaCO2) are measured before anesthesia surgery at the beginning of the fetal childbirth at the end of the operation and operation after 1 hour when recording and compare the two groups of 4.3 maternal visual analog pain score (VAS) and sedation scores (Ramsay) and the time from uterine incision to fetal childbirth are measured before anesthesia surgery at the beginning of the fetal childbirthAt the end of the operation and operation after 1 hour record and compare the two groups of 4.4 respiratory system complications within 72 h in pregnant women (hypotension sinus bradycardia nausea and vomiting respiratory depression) are record.
4.5 Apgar score 1, 5, 10 minutes after birth, umbilical arterial blood gas and neurobehavioral scores (NBNA) 2 and 24 hours after the birth are record.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Esketamine
2ml normal saline
Time frame: immediately after fetal delivery
Pain intensity was assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain)
Time frame: immediately after fetal delivery
Maternal sedation level was assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond)
Time frame: before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,
Maternal pain intensity at other timepoints were assessed with the numeric rating scale (NRS; an 11-point scale, with 0 indicating no pain and 10 indicating the worst pain)
Time frame: before anesthesia, immediately after anesthesia, surgical incision, 5 minutes after study, end of surgery, 6 hours after surgery, and 12 hours after surgery. drug administration,
Maternal sedation level at other timepoints were assessed with Ramsay Sedation Scale (with 1 indicating restless; 2, completely awake, quiet, and cooperative; 3, drowsy but responding to verbal commands; 4, lightly asleep but responding to touch or pain; 5, asleep but slowly responding to touch or pain; and 6, deeply asleep and does not respond)
Time frame: before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery
systolic and diastolic blood pressure were assessed by non-invasive blood pressure cuff,mean blood pressure was measured by the Calculation formula: Mean arterial pressure =(systolic pressure +2× diastolic pressure)/3
Time frame: before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery
maternal heart rate
Time frame: before anesthesia, immediately after anesthesia, at surgical incision, 5 minutes after study drug administration, immediately after fetal delivery, at end of surgery, and 1 hour after surgery
pulse oxygen saturation
Time frame: at 1 minute and 5 minute after birth
Apgar was assessed by appearance, pulse, grimace, activity, respiration. Each item was measured on a scale of 0, 1, and 2, respectively, with a maximum total score of 10.
Time frame: Results of umbilical arterial blood gas analysis after birth
postnatal umbilical vein blood gas pH value
Time frame: Immediately after fetal delivery
Esketamine concentrations was assessed by reverse-phase high-performance liquid chromatography
Time frame: Adverse events were recorded as Frequency of occurrence between the time the patient entered the operating room and the end of surgery
hypotension was defined as a systolic blood pressure decrease less than 20% of baseline, hypertension was defined as a systolic blood pressure increase greater than 20% of baseline, bradycardia was defined as a heart rate less than 60 beats per minute, tachycardia was defined as a heart rate greater than 100 beats per minute, and desaturation was defined as oxygen saturation less than 90%.
Time frame: 2 years after birth
Neurodevelopment was measured by the Ages and Stages Questionnaire, third edition (ASQ-3).The ASQ-3 assesses 5 developmental domains: gross motor skills, fine motor skills, problem-solving ability, communication, and personal and social skills. Each domain is assessed by 6 questions ascertaining achievement of relevant skills and answered as yes (10 points), sometimes (5 points), or not yet (0 points). Scores for individual items are summed to give an overall continuous score for each of the 5 domains (possible range, 0-60).
Time frame: at 2 years after birth
Mothers' memories of childbirth was assessed by The Birth Memories and Recall Questionnaire (BirthMARQ),which focused on parents' positive, negative or mixed emotions at the birth/in recalling the event. Each item (e.g. 'my emotions at the time were extremely negative') was rated on a scale ranging from 1 (strongly disagree) to 7 (strongly agree).
Women's Hospital School Of Medicine Zhejiang University
Other
A Multicenter Study of the Efficacy and Safety of Esketamine for Analgesia During
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